Cold Compression Wrap, Pro-Knee Wrap

Basic Information

• Brand Name: Cold Compression Wrap, Pro-Knee Wrap
• Primary DI: 00810113683676
• Version / Model: CCW-PKW
• Catalog Number: CCW-PKW
• Company Name: Manamed, Inc.
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-26
• Public Version: 2
• Public Version Date: 2026-01-12
• Public Version Status: Update
• Public Device Record Key: 69fdf4b3-bbd3-409b-a655-b2ec2c41d58c

Device Description

Pneumatic compression pump that attaches to one of our six compression wraps for elbow, hip, knee, shoulder, back, and ankle. Pump comes with a battery, screwdriver to insert the battery, and a charger. The compression wrap attachments are sold separately and have one removable cryo-gel pack. Features: -2 pneumatic ports to treat 1 or 2 areas at one time -Adjustable pressure settings: 20, 40, 60, 80, or 100 mmHg to control edema -LCD screen displays pressure to show inflation cycle -Set treatment times - 10-minute intervals up to 120 minutes with default of 30 minutes -Has a rechargeable battery for portability or use while charging -Easy-to-clean nylon material -Simple strapping system for donning & doffing

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IRP	Massager, Powered Inflatable Tube	Physical Medicine	890.5650	2
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	890.5700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30877	Single-chamber venous compression system garment, reusable	An inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the intermittent inflation of a single-chamber. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a reusable device.	No	Active
37240	Musculoskeletal hot/cold therapy pack, reusable	A non-powered device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck, nor is it designed to be dedicated to eye thermal therapy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113683676	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]